Safety and Efficacy Study of Intramuscular Uricase-PEG 20
Summary
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20
Description
Uricase is an enzyme (found in most mammals but not humans) that converts poorly soluble uric acid into highly soluble allantoin. Because humans lack uricase, they are prone to develop elevated levels of uric acid, which can form crystals in the joints and soft tissues. In those which chronically elevated uric acid, gout may develop. In the setting of acute rises in uric acid, seen for example in tumor lysis syndrome, uric acid crystals can damage the renal tubules. Uricase-PEG 20 is a recombinant uricase conjugated with multiple PEG molecules designed to prolong the half-life and decrease the immunogenicity of uricase. This study will characterize the safety, pharmacokinetics and pharmacodynamics of intramuscular Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in gout.
Study Design
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Gout
Intervention
Uricase-PEG 20
Location
MRA Clinical Research
Miami
Florida
United States
33143
Status
Recruiting
Source
EnzymeRx
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01038947
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:11:17-0400
Clinical Trials
Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
The purpose of this study is to determine whether PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid) is effective in controlling hyperuricemia in pati...
Safety and Efficacy Study of Intravenous Uricase-PEG 20
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Uricase-PEG 20.
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
This is a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning another additional treatment. ...
Assessment of Primary Care Providers' Knowledge and Beliefs Regarding Gout Management
This is a questionnaire study aimed at learning about physicians' views on the treatment of Gout.
PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treat...
PubMed Articles
Pegloticase is a recombinant mammalian uricase conjugated to polyethylene glycol approved in the United States for treatment of chronic refractory gout. It can profoundly decrease serum urate to
Gout or hyperuricemia are both well known and common diseases. The prevalence of gout is increasing worldwide. Thus, patients with gout are becoming more common. Although there are several published g...
Circulating uric acid (UA) is an important biomarker, not only in the detection and management of gout, but also in assessing the risk of related comorbidity. The impact of collection methods on clini...
Gout and cardiovascular disease: crystallized confusion.
Gout is associated with the risk of cardiovascular morbidity and mortality, but the biological relationship between the two remains uncertain. The demonstration of reduction of cardiovascular risk wit...
Urate and Osteoarthritis: Evidence For a Reciprocal Relationship.
Hyperuricemia is a common condition, and in a subset of patients leads to gout, the most common inflammatory arthritis. Osteoarthritis is the most common form of arthritis overall, and gout and osteoa...
Medical and Biotech [MESH] Definitions
Gout Suppressants
Agents that increase uric acid excretion by the kidney (URICOSURIC AGENTS), decrease uric acid production (antihyperuricemics), or alleviate the pain and inflammation of acute attacks of gout.
Benzbromarone
Uricosuric that acts by increasing uric acid clearance. It is used in the treatment of gout.
Apazone
An anti-inflammatory agent used in the treatment of rheumatoid arthritis. It also has uricosuric properties and has been used to treat gout.
Febuxostat
A thiazole derivative and inhibitor of XANTHINE OXIDASE that is used for the treatment of HYPERURICEMIA in patients with chronic GOUT.
Uricosuric Agents
Gout suppressants that act directly on the renal tubule to increase the excretion of uric acid, thus reducing its concentrations in plasma.
